RecruitingNot ApplicableNCT06453109

Focused Ultrasound for the Complex Patient

Towards Treatment of the Complex Patient: Investigations of Low-intensity Focused Ultrasound


Sponsor

Washington D.C. Veterans Affairs Medical Center

Enrollment

25 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Summary

The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question\[s\] it aims to answer are: * the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain * the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study uses focused ultrasound — sound waves directed at the brain to reduce overactive pain signals — in patients who have chronic back pain, opioid use disorder (dependency on opioid pain medications), and an anxiety disorder all at once. It aims to reduce pain and stress without adding more medications. **You may be eligible if...** - You are aged 18–75 with chronic back pain lasting at least 3 months - You have been diagnosed with opioid use disorder and are in treatment with buprenorphine or methadone - You have a current anxiety disorder (generalized anxiety, PTSD, or social anxiety) - Your pain is rated 4 out of 10 or higher on a standard scale **You may NOT be eligible if...** - You have neuropathic pain (nerve damage-related pain) - You have a substance use disorder other than opioids - You have metal implants in your head or a pacemaker - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICElow intensity focused ultrasound (LIFU)

Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects.


Locations(1)

Washington DC Veterans Affairs Medical Center

Washington D.C., District of Columbia, United States

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NCT06453109